Kornimate/medical-research-clean huggingface dataset:
cranoc lipid study in renal transplantation

Conditions: Renal Transplantation

Summary: cardiovascular disease after renal transplantation is an important problem. patients after renal transplantation with low ldl-levels (\<130mg/dl) receive fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

cardiovascular disease after renal transplantation is an important problem. patients after renal transplantation with low ldl-levels (\<130mg/dl) receive fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Eligibility criteria:
inclusion criteria: * patients (18 - 65, inclusive) * cadaver and living kidney transplantation (1. ntx, 2. ntx) * ldl-cholesterol ≤ 130mg/dl (-3 mo until start of tx) * patients with a history of myocard infarct: ldl-cholesterol ≤ 110mg/dl * immunsuppression: tacrolimus in combination with steroids or mycophenolat mofetil * patients indulgence exclusion criteria: * statin before the study * ldl-cholesterol \>130mg/dl before transplantation * instabil angina, myocard infarct \<6 months before transplantation * symptomatic hypothyreosis * child bearing, lactating * elavated liver encymes (\> 2x elavated: ast, alt, bilirubine, pck) * fibrates are not allowed * multiorgantransplantation

Keywords: renal transplantation cardiovasculary disease statin
tenofovir renal toxicity and glomerular filtration rate (gfr) validation

Conditions: Renal Function; HIV Infection

Summary: to assess and validate equation egfr in hiv-infected subjects and -uninfected thai patients

with significant reductions in mortality and risk of progression to aids with antiretroviral therapy (art), complications of long-standing hiv infection and treatment, including renal disease, have become increasingly important. aging, concomitant metabolic diseases, and use of potentially nephrotoxic art lead to higher risk for renal disease in hiv-infected persons.who encourage tdf as first line arv regimen. the data on tdf related renal toxicity in asian population is limited. for this cohort, we plan to look at these topics: 1. proximal tubular dysfunction between tdf and non-tdf user 2. incidence and predictor of tdf related renal toxicity 3. tdf plasma concentrations 4. pharmacokinetic of tdf when used with boosted drv, boosted atv, and boosted lpv in thai population 5. bone density and vitamin d in patients with and without hypophosphatemia. 6. pharmacogenomic of tdf in thai population

Eligibility criteria:
inclusion criteria: 1. \> 18 years old. 2. hiv rna \< 50 copies/ml (for art-experienced group only). exclusion criteria: 1. a history of tc-99m dtpa allergy, 2. malnutrition (bmi \<18m2), 3. amputation, 4. bed-ridden, 5. currently taking cotrimoxazole or cimetidine, 6. acute deterioration of renal function within the last 3 months, 7. serum creatinine \> 1.5 mg/dl, or 8. pregnant/lactating.

Keywords: hiv chronic kidney disease glomerular filtration rate (gfr) tenofovir serum creatinine (scr) 24 hr urine creatinine clearance serum cystatin c[40] modification of diet in renal disease (mdrd) cockcroft gault equation chronic kidney disease epidemiology collaboration (ckd-epi) 99mtc-diethylenetriaminepentaacetic acid (tc-99m dtpa) scan validate which renal function assessments can accurately detect gfr and assess the effect of tdf concentration on renal function
a phase 2b study to evaluate rezpegaldesleukin (rezpeg) in the treatment of adult patients with moderate-to-severe atopic dermatitis

Conditions: Moderate to Severe Atopic Dermatitis

Summary: this is an interventional, randomized, parallel group, treatment, phase iib, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. the estimated duration is 15-35 days for screening, an induction period of 16 weeks, a maintenance period from week 16-week 52, and a posttreatment follow-up period for an additional year up to approximately week 104 for all patients. patients with a response at week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.


Eligibility criteria:
inclusion criteria: * adults (from at least 18 years of age) with ad as defined by the american academy of dermatology consensus criteria for 1 year or longer prior to screening. * ad disease severity at screening and randomization: * easi of 16 or higher * iga of 3 or 4 * bsa of 10% or more * documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments. * able to complete patient questionnaires. * able and willing to comply with requested study visits and procedures. * able and willing to provide written informed consent. exclusion criteria: * prior use of systemic immune modulating therapies for ad (i.e., jak inhibitors or biologics) * other skin conditions that would interfere with assessment of ad * treatment with a live (attenuated) immunization within 12 weeks prior to screening. * men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding. * any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization). * known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) at screening. * severe concomitant illness that would in the investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. * concurrent participation in any other investigational clinical study.
pool-based exercise in fibromyalgia management

Conditions: Fibromyalgia

Summary: pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. the objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and ai chi. each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. main outcome measures are the fibromyalgia impact questionnaire (fiq) and the pittsburgh sleep quality index (psqi). secondary outcome measures include the beck depression inventory (bdi), the state and trait anxiety inventory (stai), and the sf-12 health survey (sf-12. data analysis will be done using repeated measures anova, unpaired student's t test, and effect sizes' estimation (es).


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia according to the acr criteria * 18 years or older * written informed consent to participate exclusion criteria: * unable to tolerate warm chlorinated water * associated medical condition contraindicating exercise in warm water

Keywords: fibromyalgia pool-based exercise
inpatient covid-19 lollipop study

Conditions: COVID-19; Diagnostic Test

Summary: this study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for covid-19 polymerase chain reaction (pcr) testing. 225 covid-positive participants aged 4 years and above admitted to a hospital in the madison, wisconsin metropolitan area will be enrolled over a 6 month period.

this is a prospective quantitative study evaluating the utility of a novel method of saliva collection for covid-19 testing. primary objective * to determine the performance characteristics of oral lollipop swabs compared to nasal pharyngeal (np) swabs for diagnosing covid-19 via pcr molecular testing. secondary objectives * to identify clinical characteristics of patients when there are discordant results for np and oral lollipop test results.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to provide verbal informed consent, if 18 years or older. if 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent. * willing to comply with all study procedures and be available for the duration of the study. * admitted to uw health university hospital or uw health kids american family children's hospital. * individuals at least 4 years of age. * verified covid-19 according to positive np pcr test criteria. * enroll within 47 hours of the diagnostic np swab; lollipop swab collected within 48 hours of the diagnostic np swab. * either personally able or have a parent or legal guardian able to verbally answer questions in english about clinical symptoms, exposures, and other health and demographic information. exclusion criteria: * unable to suck on a swab. * previous participation in this study. * require translation services for medical care. * not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
a study of the safety and effects of emd 72000 in subjects with recurrent ovarian cancer

Conditions: Ovarian Cancer

Summary: emd 72000 is an experimental, biological drug. studies in animals indicate that emd 72000 blocks a factor found on the surface of many cancer cells. the factor is called epidermal growth factor receptor or egfr. one type of cancer which frequently contains egfr is ovarian cancer. this study will test the safety and effects of emd 72000 in subjects with egfr-positive recurrent ovarian cancer following standard treatment that has failed.


Eligibility criteria:
inclusion criteria: * recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin hcl liposome, topotecan, etc.) for primary or secondary platinum-refractory disease * immunohistochemical evidence of tumor egfr (her-1) expression * at least one measurable lesion according to the who criteria * life expectancy ≥ 12 weeks * ecog performance status 0-1 exclusion criteria: * history of prior mab therapy * history of prior treatment with an egfr (her-1) directed therapy * known brain metastases * presence of a ≥ grade 2 pre-existing skin disorder (alopecia is permitted) * known intercurrent infections or immunosuppression * actively infected with, or chronic carriers of hbv * evidence of hcv disease * previous diagnosis of autoimmune disease * known hypersensitivity to the administered drugs or any of their components * receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

Keywords: egfr; her-1; monoclonal antibody; targeted therapy
using ar dental care training on periodontal status, blood sugar control and qol in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2 With Periodontal Disease

Summary: the aim of this study was to evaluate the long-term effectiveness of an ar dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. this randomized controlled trial included experimental group: ar group (eg-ar), ar health consulting group (eg-arhc) and control group (cg), respectively. the eg-ar and eg-arhc received ar dental care training intervention 2 to 3 times during non-surgical periodontal treatment. baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health related quality of life.

a randomized experimental design was used. patients with type 2 diabetes whose aged 35-65 years and hba1c over 7% in the past six months were recruited through department of endocrinology and metabolism in chimei hospital yongkang and liuying campus. each group was expected for 100 per group, patients will be randomized into each group. g\*power (version 3.1.9.4) was used for power analysis. all patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1-year follow-ups. each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth. each patients will completed the questionnaire at baseline and at 1-month, 3- month, 6-month and 1-year follow-ups.

Eligibility criteria:
inclusion criteria: * age 35 years old (inclusive) and above * hba1c over 7% in the past six months * there are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition exclusion criteria: * have received periodontal treatment within the previous 6 months * habits of smoking, drugs and betel nut chewing * taking antibiotics and osteoporosis bisphosphonates and other drugs regularly * people with cognitive function or physical and mental disabilities * severely impaired diseases (for example: cancer, renal function or liver failure, etc.)

Keywords: augmented reality periodontal health blood sugar control type 2 diabetes mellitus
dose-ranging study with glpg0634 in methotrexate-refractory active rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: * ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking glpg0634 (4 different doses will be evaluated) or matching placebo for 4 weeks. * during the course of the study, patients will also be examined for any side effects that may occur, and the amount of glpg0634 present in the blood as well as the effects of glpg0634 on disease- and mechanism of action-related parameters in the blood will be determined.


Eligibility criteria:
inclusion criteria: * have active ra as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum crp ≥1.0 mg/dl; * have received methotrexate for 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study; * if taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to screening; * if taking non-steroidal anti-inflammatory drugs (nsaids), these must be at a stable dose for at least 2 weeks prior to screening; * female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year; * women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug. * sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and * able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments. exclusion criteria: * treatment with disease-modifying antirheumatic drugs (dmards), other than background methotrexate; * current or previous ra treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other b cell depleting agents); * previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening; * previous use of the study drug glpg0634; * receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening; * known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator; * positive serology for hiv1 or 2 or hepatitis b or c, or any history of hepatitis from any cause with the exception of hepatitis a; * history of any inflammatory rheumatological disorders other than ra; * history of tuberculosis (tb) infection

Keywords: methotrexate insufficient responders
component and couple analysis of cancer communications

Conditions: Breast Cancer

Summary: component and couple analysis of cancer communication chess, the comprehensive health enhancement support system is an innovative technology that provides information, social support and skills training to women with breast cancer. previous chess clinical trials found improved patient outcomes but little is known about what services in chess produce those results. this study will examine whether breast cancer patient outcomes change when conceptually distinct chess services (information, social support, and skills training) are systematically added to a patients treatment resources. primary aims: * determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination * determine routes or processes via which these elements work * determine for whom the different treatment types work best.


Eligibility criteria:
inclusion criteria: eligibility for this protocol is as follows: * all subjects must be within 2 months of their primary breast cancer diagnosis, * all subjects must be at least 18 years of age, * all subjects must be able to read and write english at the 6th-grade level * not homeless

Keywords: breast cancer internet computer support information education control group: usual care and internet access chess information services only chess social support & information services chess information, social support & skills services
study to learn more about outcomes reported by patients suffering from type 2 diabetes using a digital data collection tool

Conditions: Diabetes Mellitus, Type 2

Summary: in this study researchers want to gain more information on patients who are treated with metformin for their type 2 diabetes. adult female and male patients with a prescription of a metformin containing drug will be invited to the study in a public pharmacy after the decision for treatment with metformin has been made by the treating physician. the pharmacist will provide interested participants access to a special phone app and participants are asked to complete via this phone app a questionnaire on their health situation with special focus on their type 2 diabetes. this includes questions on complications and self-care activities in relation to their diabetes, questions on quality of life and health history. there will be no extra visit to the treating doctor or a pharmacy. the study is aiming to have the questionnaire completed by 300 participants.


Eligibility criteria:
inclusion criteria: * adult female or male patient * valid prescription for a metformin containing drug approved in germany * decision to initiate treatment with metformin was made by the treating physician as part of the routine treatment practice * signed informed consent exclusion criteria: - not applicable

Keywords: diabetes mellitus, type 2
investigation of tumour spectrum of germline mutations in breast and ovarian cancer genes.

Conditions: Hereditary Breast and Ovarian Cancer; Mutation

Summary: tumospec is a national family study designed to measure the relative and absolute risk of cancer for carriers of deleterious mutations to these "new" breast cancer (bc) susceptibility genes. index cases will be enrolled consecutively from patients attending an appointment at one of the unicancer centres, with no other inclusion criteria, and offered a brca1/2 analysis as part of their care plan. a panel of 24 tumospec genes, chosen in advance by a steering committee, will be tested as the same time as the brca1/2 genes, at one of the usual brca1/2 analysis laboratories belonging to the same network and participating in the study. if a mutation is found, the index cases will be asked to invite their first and second degree family members and their cousins to take part in the study, regardless of whether they have cancer. saliva samples will be then taken and used for a targeted analysis of the familial abnormality. each participant will also complete an epidemiological questionnaire in order to gather information about his/her medical history and any exposure to various risk factors. all medical and genotype data will be centralised at the genetic epidemiology research platform (pige, inserm). the cumulative mutation frequency for all genes is estimated at 10%. penetrance will be analysed using methods designed to minimise selection bias. the expression spectrum of the mutations will also be described. for genes where the number of mutated families is too low, the data may be contributed to international consortia. the main project will be preceded by a two-year feasibility study, using the same inclusion criteria and logistic circuits. it is this pilot study to which the current funding application relates.


Eligibility criteria:
inclusion criteria: index case eligibility: any person with an indication for a brca1/brca2 gene analysis and who has been offered tumospec panel screening. age ≥18 years. family member eligibility: family members will be eligible if the mutation identified in the index case is considered deleterious. any family member to the first and second decree or a cousin of the index case. family members from both sides of the family will be invited to take part. age ≥18 years. exclusion criteria: people deprived of their civil liberties or who are under judicial protection or guardianship. patients unable to answer the questionnaire for social or psychological reasons. children of the index cases, of any age.

Keywords: oncogeneticists mutations breast cancer ovarian cancer
preservation of inferior mesenteric artery could improve sexual function after laparoscopic colorectal resection for diverticular disease

Conditions: Sexual Function Disturbances

Summary: this study aims to evaluate whether ima sparing may represent an advantage in terms of reduced incidence and severity of sexual dysfunctions after colorectal resections for diverticular disease (dd).

enrolled patients were randomly divided into 2 treatment groups. in the first group (imap) the ima was preserved sectioning the sigmoid arteries near colonic wall while, in the second group (imas) the ima was sectioned immediately below the origin of the left colic artery. incidence and severity of sexual dysfunction and qol were assessed by four validated questionnaire administered 6,12 months and 5 and 8 years after surgery.

Eligibility criteria:
inclusion criteria: * diverticular disease * diverticulitis * bmi under 35 kg/mq * asa score from i to iii * standardized sigmoid, left colon or rectal resection exclusion criteria: * complicated diverticulitis (hinchey iii-iv) * previous abdominal surgery or prostatic and/or gynecological resections * adverse local condition or the need of multiorgan resection or stoma creation

Keywords: sexual function colonic diverticular disease inferior mesenteric artery-preserving neosigmoid denervation postoperative sexual dysfunction